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

Purpose:

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.

Method:

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.

Results:

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

Conclusion:

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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