Session Information
Date: Tuesday, October 23, 2018
Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose:
Secukinumab has demonstrated rapid and sustained improvements in the signs and symptoms of ankylosing spondylitis (AS) across multiple randomized controlled trials. Using pooled data from MEASURE 1, 2 and 4 (NCT01358175; NCT01649375; NCT02159053), this comprehensive analysis investigated the effect of secukinumab on health-related quality of life (HRQoL), assessed by the Short Form-36 Health Survey (SF-36), in TNF inhibitor (TNF)-naïve and TNF inhibitor-inadequate responder/intolerant (TNF-IR) patients (pts) with AS.
Methods:
Pts with active AS were randomized to secukinumab (10 mg/kg intravenously followed by 150 or 75 mg subcutaneously [SC] in MEASURE 1; 150 or 75 mg SC in MEASURE 2; and 150 mg SC with/without loading in MEASURE 4) or placebo (PBO) for 16 wks, stratified by prior TNF inhibitor therapy. At Wk 16 (or Wk 24 in MEASURE 1 depending on ASAS20 response), pts on PBO were switched to secukinumab. Mixed-model for repeated measures was used to assess change in SF-36 from baseline (BL) up to Wk 16; observed data are presented at Wk 52. The proportion of pts reporting improvements meeting or exceeding the minimal clinically important differences (MCID) for SF-36 physical (PCS responders), mental component summary (MCS responders) and individual SF-36 domains was assessed. Missing data were imputed as non-response, and the proportion of responders at Wk16 were compared between treatment groups using Fisher’s exact test. Pooled data for pts receiving the licensed dose of secukinumab (150 mg) or PBO are shown.
Results:
A total of 743 pts were included: 430 and 313 in the secukinumab 150 mg and PBO groups, respectively, of whom approximately 30% were TNF-IR. The least squares mean changes from BL to Wk 16 in SF-36 were significantly greater with secukinumab 150 mg vs PBO for PCS (6.09 vs 2.75; p<0.0001), MCS (4.40 vs 2.45; p<0.01), and all individual domain scores. Similar improvements were reported with secukinumab 150 mg vs PBO in TNF-naïve pts at Wk 16 (PCS: 7.23 vs 3.40, p<0.0001; MCS: 5.22 vs 2.92, p<0.01). In TNF-IR pts, PCS score was significantly improved with secukinumab 150 mg vs PBO at Wk 16 (4.79 vs 2.44; p<0.05). There was a significantly higher proportion of PCS responders in the secukinumab 150 mg group at Wk 16 vs PBO, regardless of TNF status (Table). Similar results were reported for all individual domains in the overall population. Consistent trends for higher response rates in favour of secukinumab 150 mg were observed in both TNF subgroups, with the TNF-naïve subgroup reaching statistical significance across all individual domains except mental health. Improved PCS, MCS, individual domain scores and responder rates were sustained to Wk 52 with secukinumab 150 mg.
Conclusion:
Secukinumab 150 mg resulted in significant, clinically meaningful, and sustained improvements in HRQoL (SF-36) up to Wk 52 in both TNF-naïve and TNF-IR pts with AS.
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Table. Proportion of SF-36 responders (≥2.5 point improvements in PCS and MCS; ≥5 points for individual domains) at Wks 16 and 52 in the overall, TNF-naïve, and TNF-IR groups in a pooled analysis from MEASURE 1, MEASURE 2, and MEASURE 4 RCTs. |
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|
Responder rates (%) |
Secukinumab 150 mg |
Placebo |
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|
Week 16 |
Week 52 |
Week 16 |
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|
Overall |
TNF-naïve |
TNF-IR |
Overall |
TNF-naïve |
TNF-IR |
Overall |
TNF-naïve |
TNF-IR |
|
|
PCS |
71.4* |
75.8* |
60.5** |
68.6 |
74.2 |
54.8 |
46.6 |
50.2 |
38.5 |
|
MCS |
53.7 |
55.2 |
50.0 |
52.8 |
54.6 |
48.4 |
47.9 |
51.2 |
40.6 |
|
Physical functioning |
73.3** |
76.8** |
64.5 |
71.6 |
74.8 |
63.7 |
58.5 |
61.3 |
52.1 |
|
Role-physical |
68.1** |
73.2** |
55.6 |
67.9 |
72.5 |
56.5 |
52.4 |
56.2 |
43.8 |
|
Bodily pain |
73.3* |
76.1* |
66.1 |
71.9 |
75.8 |
62.1 |
55.0 |
57.1 |
50.0 |
|
General health |
62.8* |
67.0* |
52.4 |
60.2 |
64.4 |
50.0 |
45.0 |
46.5 |
41.7 |
|
Vitality |
66.5*** |
70.3** |
57.3 |
65.8 |
69.3 |
57.3 |
55.3 |
57.1 |
51.0 |
|
Social functioning |
61.9** |
66.0** |
51.6 |
60.0 |
62.7 |
53.2 |
49.5 |
50.7 |
46.9 |
|
Role-emotional |
54.7*** |
56.9*** |
49.2 |
52.6 |
55.6 |
45.2 |
43.8 |
44.2 |
42.7 |
|
Mental health |
60.9*** |
62.7 |
56.5 |
61.2 |
63.7 |
54.8 |
50.8 |
53.9 |
43.8 |
|
* p < 0.0001; ** p < 0.01, *** p < 0.05 versus placebo. MCS, mental component summary; PBO, placebo; PCS, physical component summary; RCT, randomized controlled trial; TNF-IR, tumor necrosis factor inhibitor-inadequate responder; TNF-naïve, tumor necrosis factor inhibitor-naïve. PCS and MCS response: patients with ≥2.5 point increase in SF-36 component summary score (PCS and MCS) Individual domain response: patients with ≥5.0 point increase in SF-36 individual domain score |
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To cite this abstract in AMA style:
Deodhar AA, Boonen A, Ferraccioli G, van Den Bosch F, Martinez D, Porter B, Shete A, Scheuer N, Gilloteau I, Strand V. Secukinumab Provides Early and Sustained Improvements in Health-Related Quality of Life in Patients with Ankylosing Spondylitis: A Pooled Analysis from the Secukinumab Phase 3 Trial Program [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/secukinumab-provides-early-and-sustained-improvements-in-health-related-quality-of-life-in-patients-with-ankylosing-spondylitis-a-pooled-analysis-from-the-secukinumab-phase-3-trial-program/. Accessed .« Back to ACR/ARHP Annual Meeting 2018
ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-provides-early-and-sustained-improvements-in-health-related-quality-of-life-in-patients-with-ankylosing-spondylitis-a-pooled-analysis-from-the-secukinumab-phase-3-trial-program/