Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.

Effect of Canakinumab (Ilaris, a Fully Human Anti-IL-1 beta Monoclonal Antibody) On the Health-Related Quality of Life (HRQoL) in Cryopyrin-Associated Periodic Syndrome (CAPS) Patients

Kuemmerle-Deschner1,  J.B., Hoyer2,  J., Hachulla3,  E., Chaturvedi4,  R., Blank5,  N., Hiepe6,  F., Ferreira7,  A.

Universitätsklinikum Tübingen, Klinik fuer Kinder- und Jugendmedizin, Tübingen, Germany,
Univ.-Klinikum Gießen und Marburg, Marburg, Germany,
Hôpital Claude Huriez CHRU, Lille, France,
Pushpawati Singhania Research Institute, New Delhi, India,
Medizinische Klinik 5, Universitätsklinikum Heidelberg, Heidelberg, Germany,
Charité- Universitätsmedizin Berlin, Berlin, Germany,
Novartis, Basel, Switzerland


Patient's QoL is markedly affected by the persistent disease features of CAPS. Canakinumab treats the underlying causes of CAPS by potent, rapid, and selective blockade of IL-1b. This Phase II, open-label study evaluated the improvement in the HRQoL following canakinumab treatment in CAPS patients.


The study was conducted in CAPS patients with confirmed NLRP3 mutation. Patients received a single dose of canakinumab 150 mg or 2 mg/kg s.c. (patients <=16 yrs) with redosing upon each relapse. HRQoL of adult patients were assessed at baseline and during treatment by patient reported outcomes for fatigue (FACIT-Fatigue©), general mental and physical health (SF-36©), and functional disability (HAQ-DI©). Increases from baseline FACIT-Fatigue and SF-36 scores, and decrease from baseline HAQ-DI scores indicate improvement in HRQoL.


The mean baseline scores for FACIT-Fatigue (31.22) and SF-36 mental (43.02) and physical (37.98) component scores were significantly lower than scores expected in the general population (i.e., 43.6 for FACIT-Fatigue and 50 for both SF-36 component scores, respectively)1,2, confirming the detrimental impact CAPS has on patient's quality of life. HAQ-DI baseline mean score was 0.42 on a scale of 0 (no disability) to 3 (maximum disability). Ten out of 18 patients had functional disability as assessed by HAQ-DI (range 0.13 to 2.5). Canakinumab patients improved their HRQoL scores following a single injection (See Table). Improvements were seen as early as one day after the first single dose and maintained for 5 weeks. FACIT-Fatigue (45.6) as well as SF-36 mental (54.84) and physical component scores (49.52) reached levels comparable to average scores of the general population. Similarly, HAQ-DI improved by 0.2 units 5 weeks after canakinumab administration. HRQoL decreased again prior to canakinumab re-dosing when patients started experiencing a disease flare.

Table. Summary of FACIT-Fatigue, SF-36 and HAQ-DI summary scores by time following a single dose of canakinumab (1st period)

    FACIT-Fatigue 0–52SF-36 (MCS) 0–100SF-36 (PCS) 0–100HAQ-DI 0–3
  Average general population score1,2 (SD)43.6 (9.4)50* (10)50* (10) NA
Dose regimenTime-point nMean (SD)nMean (SD)nMean (SD)nMean (SD)
 Baseline 1831.22 (13.41)1843.02 (10.39)1837.98 (11.14)180.42 (0.79)
Canakinumab 150mg sc1 day post-dose 1935.63 (15.31)1541.02 (11.22)1541.20 (12.69)190.36 (0.72)
 1 week post-dose 1945.05 (11.01)1847.75 (8.46)1845.86 (9.49)190.19 (0.53)
 5 weeks post-dose 1545.60 (9.50)1454.84 (7.25)1449.52 (8.36)150.23 (0.58)
 Prior re-dose 1736.68 (12.56)1748.40 (9.43)1741.74 (13.48)170.34 (0.62)
MCS, Mental component; PCS, Physical component; NA, Not available;
*Scores were normalized so that a score of 50 represented an average US person with no chronic disease; The 1st period includes data from inclusion when patient was flaring to the first relapse; Prior re-dose= assessment when patient experienced next flare


Canakinumab improved the HRQoL in CAPS patients assessed by FACIT- Fatigue, SF-36 mental and physical scores to a level of average scores of the general population and improved functional disability index.

1.Ware, J, Kosinski, M & Keller, SKSF-36® Physical and Mental Health Summary Scales: A User's Manual. Boston, MA: The Health Institute. 1994

2.Cella, D, Lai, J, Chang, C, Peterman, A & Slavin, MCancer 2002;94:528–38

To cite this abstract, please use the following information:
Kuemmerle-Deschner, J.B., Hoyer, J., Hachulla, E., Chaturvedi, R., Blank, N., Hiepe, F., et al; Effect of Canakinumab (Ilaris, a Fully Human Anti-IL-1 beta Monoclonal Antibody) On the Health-Related Quality of Life (HRQoL) in Cryopyrin-Associated Periodic Syndrome (CAPS) Patients [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1483
DOI: 10.1002/art.26557

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