Session Information
Session Type: Abstract Submissions (ACR)
Ustekinumab Improves Arthritis-related and Skin-related Quality of Life in Patients with Active Psoriatic Arthritis: Patient Reported Outcomes from Randomized and Double Blinded Phase III PSUMMIT I Trial
Background/Purpose: To examine the impact of ustekinumab treatment on general and disease specific patient reported outcomes (PROs) of patients with active psoriatic arthritis (PsA) using data from PSUMMIT 1, a Phase 3 clinical study.
Methods: In PSUMMIT I, adult PsA patients (n=615) with active disease despite DMARD and/or NSAID therapy were randomized to receive ustekinumab 45mg, 90mg, or placebo (PBO) at wks 0, 4, and q12wks, thereafter. Patients treated with prior anti-TNF agents were excluded. At wk16, patient with <5% improvement in swollen and tender joint counts entered blinded early escape (PBO→ ustekinumab 45mg; ustekinumab 45mg→90mg; 90mg→90mg). Patient reported outcomes were measured with Health Assessment Questionnaire (HAQ), Dermatology Quality Life Index (DLQI), SF–36 health survey questionnaire (SF-36), Visual Analogue Scales (VAS) for impact of PsA on work productivity (0-10), patient assessment of pain (0-10) and disease activity (0-10). An ANOVA on van der Waerden normal scores was used for continuous variables and chi-square or the Cochran-Mantel-Haenszel (CMH) test for binary variables between groups.
Results: At baseline, PRO measures indicated that the study population had severe physical disability and impaired health related quality of life with a mean HAQ score of 1.25 and mean DLQI score of ≥10. At wk 24, greater improvements in HAQ, DLQI, and SF-36 PCS were observed in ustekinumab groups compared to the PBO group. Proportions of patient who achieved clinical meaningful improvements in HAQ (≥0.3), DLQI (≥5), and SF-36 PCS (≥5) were greater in the ustekinumab 45mg or 90 mg group than in the PBO group. Additionally, ustekinumab-treated patients also achieved greater improvements in patient assessment of pain, patient assessment of disease activity and greater reduction in impact of disease on work productivity than PBO-treated patients (Table).
Conclusion: Ustekinumab improves general as well as arthritis and skin-related quality of life, and reduces the impact of disease on work productivity in patients with active PsA.
Table: Baseline Characteristics and Change in Patient Reported Outcomes
at Week 24 by Treatment Group: Results from PSUMMIT I
|
PROs at Week 24 |
PBO (N=206) |
Ustekinumab 45mg (N=205) |
Ustekinumab 90mg (N=204) |
|
Age (years) |
47.4 |
47.1 |
46.8 |
|
Male Gender (%) |
52.4 |
51.7 |
56.9 |
|
Baseline HAQ (0-3) |
1.2 |
1.2 |
1.2 |
|
Baseline DLQI (0-30)a |
11.7 |
11.0 |
10.5 |
|
Baseline SF-36 PCS (0-100) |
36.2 |
35.7 |
36.5 |
|
Baseline SF-36 MCS (0-100) |
41.9 |
43.1 |
42.1 |
|
Mean improvement in DLQI |
1.4 |
6.6⁺⁺ |
7.5⁺⁺ |
|
Achieving DLQI score of 0 or 1 (%) |
8.3 |
37.2⁺⁺ |
53⁺⁺ |
|
Mean improvement in HAQ |
0.1 |
0.31⁺⁺ |
0.4⁺⁺ |
|
Improvement in HAQ≥0.3 (%) |
28.2 |
47.8⁺⁺ |
47.5⁺⁺ |
|
Mean Change in SF36 PCS |
0.3 |
3.0⁺⁺ |
3.3⁺⁺ |
|
Improvement in SF-36 PCS ≥5 (%) |
17.9 |
30.5⁺ |
38.1⁺⁺ |
|
Mean Change in SF-36 MCS |
1.2 |
0.5 |
2.5* |
|
Improvement in SF-36 MCS ≥5 (%) |
30.1 |
23 |
36.5 |
|
Percent improvement in pain |
4.5 |
25.9 ⁺⁺ |
29.6 ⁺⁺ |
|
Percent improvement in disease activity |
7.6 |
25.4 ⁺⁺ |
27.6 ⁺⁺ |
|
Mean improvement in productivity |
0.78 |
1.82 ⁺⁺ |
2.64 ⁺⁺ |
Data presented were mean or percent; Compared with PBO, * p<0.05, ⁺, p<0.01; ⁺⁺, p<0.001;
a: Footnote DLQI only for Patients with baseline BSA>=3%.
Disclosure:
A. Kavanaugh,
Janssen Research and Development, LLC,
;
I. B. McInnes,
Janssen Research and Development, LLC,
9;
A. B. Gottlieb,
Janssen Research and Development, LLC,
;
L. Puig,
Janssen Research and Development, LLC,
;
P. Rahman,
Janssen Research and Development, LLC,
;
C. T. Ritchlin,
Janssen Research and Development, LLC,
;
S. Li,
Janssen Research and Development, LLC,
3;
Y. Wang,
Janssen Research and Development, LLC,
3;
C. Han,
Janssen Services, LLC,
3;
A. Mendelsohn,
Janssen Research & Development, LLC,
3;
M. K. Doyle,
Janssen Research and Development, LLC,
3.
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