Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Rapid Improvement in Health-Related Quality of Life (HRQoL) in Gouty Arthritis Patients Treated with Canakinumab (ACZ885) Compared to Triamcinolone Acetonide.

So6,  A., Meulemeester4,  M. De, Pikhlak2,  A., Yucel1,  A. E., Arulmani3,  U., Richard3,  D., Stricker3,  K.

Baskent University, Ankara, Turkey
Moscow State University of Medicine and Dentistry, Moscow, Russian Federation
Novartis Pharma AG, Basel, Switzerland
Private PracticeGozée, Gozée, Belgium
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ
University of Lausanne, Lausanne, Switzerland

Background:

Gouty arthritis is a painful inflammatory disease with a significant impact on patients' HRQoL. In gouty arthritis, the inflammatory response is initiated by interleukin-1b (IL-1b) release, due to activation of the NALP3 inflammasome by MSU crystals. Canakinumab, a fully human anti-IL-1b antibody has a long half-life and has been shown to control inflammation in gouty arthritis. This study evaluated changes in HRQoL in gouty arthritis patients following treatment with canakinumab or triamcinolone acetonide (TA).

Methods:

This was an 8-week, dose-ranging, multi-center, active controlled, single-blind study. Patients (>=18 to <=80 years) experiencing an acute gouty arthritis flare, refractory to or contraindicated to NSAlDs and/or colchicine, were randomized to canakinumab 10, 25, 50, 90, 150 mg sc or TA 40 mg im. HRQoL was assessed as an exploratory endpoint at baseline and different pre-specified time-points using patient reported outcomes evaluating general mental and physical component summary scores and subscale scores of SF-36® (acute version 2) and functional disability (HAQ-DI©). We report HRQoL results for canakinumab 150 mg, the dose that was selected for the Phase III studies.

Results:

Baseline assessments showed a major impact on the HRQoL during acute gouty arthritis. Compared to TA, canakinumab 150 mg showed greater improvements in SF-36® physical and mental component summary and subscale scores at 7 days post-dose.

In the canakinumab 150 mg group, the most severe impairment at baseline was reported for physical functioning and bodily pain; levels of 41.5 and 36.0, respectively, which improved within 7 days to 80.0 and 72.2 (mean increases of 39.0 and 35.6) approaching levels of the general US population (84.2 and 75.2). 8 weeks post-dose patients reached levels of 86.1 and 86.6 (mean increases of 44.6 and 50.6 for physical functioning and bodily pain, respectively) and these were higher than levels seen in the general US population. This was in contrast to patients treated with TA, who showed less improvement within 7 days (mean increases of 23.3 and 21.3 for physical function and bodily pain, respectively). None of the scores reached levels of the general US population 8 weeks post-dose. Functional disability scores, as measured by the HAQ-DI© decreased in both treatment groups (Table).

Table. Comparison of HRQoL scores of gouty arthritis patients treated with canakinumab and triamcinolone acetonide

ComponentGeneral US population†Canakinumab 150 mg s.c.Triamcinolone acetonide 40 mg i.m.
  Baseline N = 277 days post-dose N = 26†Baseline N = 567 days post-dose N = 54†
  ScoreScoreChange from baselineScoreScoreChange from baseline
SF-36 scores (0–100)       
  Physical component summary score50.0* (10.0)36.4 (8.2)48.3 (8.6)12.0 (10.0)33.5 (9.2)41.9 (9.4)8.5 (10.4)
  Mental component summary score50.0* (10.0)46.7 (13.6)50.7 (11.2)*3.4 (11.0)44.7 (15.1)47.9 (12.4)2.9 (13.5)
SF-36 subscale scores       
  Physical functioning84.2 (23.3)41.5 (30.2)80.0 (25.5)39.0 (30.9)38.4 (26.5)61.5 (29.3)23.3 (34.6)
  Role-physical80.9 (34.0)53.0 (32.5)71.2 (26.8)18.3 (28.7)43.2 (25.4)60.5 (29.0)17.4 (32.4)
  Bodily Pain75.2 (23.7)36.0 (26.6)72.2 (22.0)35.6 (38.8)32.4 (25.7)53.7 (28.6)21.3 (35.3)
  General health71.9 (20.3)65.4 (18.0)71.2 (18.5)4.6 (8.6)56.0 (20.2)61.8 (20.7)5.5 (18.3)
  Vitality60.9 (20.9)53.9 (20.5)66.6 (18.5)*12.3 (19.5)48.9 (25.3)58.6 (25.5)9.8 (24.7)
  Social functioning83.3 (22.7)61.6 (32.1)81.7 (23.5)18.8 (28.3)52.5 (29.9)70.1 (28.3)17.1 (32.5)
  Role-emotional81.3 (33.0)63.9 (32.6)80.8 (25.0)16.3 (32.1)66.5 (31.5)72.1 (27.4)6.2 (33.3)
  Mental health74.7 (18.1)67.4 (21.1)78.1 (18.2)*9.6 (14.4)60.5 (25.1)68.5 (22.8)8.5 (23.3)
HAQ-DI (0–3)NA0.8 (0.7)0.3 (0.4)-0.5 (0.7)1.1 (0.7)0.6 (0.6)-0.5 (0.5)
Mean (SD) values are presented through-out;
†for some scores evaluations were missing for up to 3 patients of the group;*normalized scores representing an average US person with no chronic disease; *reached general population levels; NA, not available

Reference: 1.

1.Ware, J et al. SF-35 Physical and Mental Health Summary Scales: A User's Manual, Boston, MA: The Health Institute, 1994

Conclusions:

All canakinumab doses showed a rapid improvement in physical and mental well-being of gouty arthritis patients based on SF-36® scores, in particular the 150 mg dose. In contrast to the TA group, patients treated with canakinumab showed improvement within 7 days in physical function and bodily pain approaching levels of the general population. The 150 mg dose of canakinumab was selected for further development in Phase III studies.

To cite this abstract, please use the following information:
So, A., Meulemeester, M. De, Pikhlak, A., Yucel, A. E., Arulmani, U., Richard, D., et al; Rapid Improvement in Health-Related Quality of Life (HRQoL) in Gouty Arthritis Patients Treated with Canakinumab (ACZ885) Compared to Triamcinolone Acetonide. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1423
DOI: 10.1002/art.29189

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