Session Information
Date: Sunday, November 5, 2017
Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: To evaluate the efficacy of ustekinumab (UST) by prior treatment exposure and disease duration in adult PsA patients (pts) in the Phase 3 trials PSUMMIT 1 and PSUMMIT 2.
Methods: Pts had active PsA (≥5 swollen, ≥5 tender joints, CRP ≥ 3.0mg/L,) for ≥6 mos despite treatment with csDMARDs and/or NSAIDs (PSUMMIT 1) or csDMARDs, NSAIDs, and/or anti-tumor necrosis factor (TNF) agents (PSUMMIT 2). In both studies, pts were randomized to SC injections of placebo (PBO) or UST 45mg or 90mg at wks 0, 4 and every 12 wks. PBO pts crossed over to UST 45mg at wk 24. At wk 16, early escape (PBOàUST45mg; UST45mgàUST90mg; UST90mgàUST90mg) was possible. Stable doses of MTX were allowed. Pooled data from both PSUMMIT 1 and 2 were analyzed. Efficacy assessments included ACR response, DAS28-CRP response, DAS28-CRP remission (score <2.6), changes in enthesitis (modified MASES index) and dactylitis scores, and total van der Heijde-Sharp (vdH-S) score for radiographic progression. Pts who were anti-TNF-naïve, MTX- and anti-TNF-naïve, all csDMARD- and anti-TNF-naïve were evaluated. ACR response at wks 4 and 16 to assess for early efficacy was also evaluated for anti-TNF-naïve pts with PsA duration <1 year, ≥1 to <3 years, and ≥ 3 years.
Results: In the pooled data, 747 pts were anti-TNF-naïve (53.8% were male; mean age=47 years); 179 pts were MTX- and anti-TNF-naïve (63.7% were male; mean age =47 years); 146 pts were all csDMARD- and anti-TNF-naïve (61.0% male; mean age=46 years). In all three prior treatment populations, significantly greater proportions of pts in the combined UST group vs PBO achieved an ACR20, ACR50, or ACR70 at wk 24. (Table). Similarly, greater proportions of pts in the combined UST group had DAS28-CRP response or remission vs PBO across all three prior treatment populations. In anti-TNF-naïve pts, improvements in enthesitis and dactylitis were significantly greater in the combined UST group vs PBO, and mean change in total vdH-S score was significantly greater for pts in the PBO group than the combined UST group; comparable trends were observed for the MTX- and anti-TNF-naïve pts and all csDMARD- and anti-TNF-naïve pts, but did not reach statistical significance due to the smaller sample sizes in both subgroups. Among anti-TNF-naïve pts treated with UST, ACR20/50/70 response rates were similar across different PsA disease duration groups at early time-points (either wk 4 or wk 16).
Conclusion: UST-treated patients had greater improvements in signs and symptoms of PsA regardless of prior treatment exposure and disease duration.
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Table. Efficacy at week 24 in PSUMMIT 1 and PSUMMIT 2 combined. |
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Anti-TNF-naive |
MTX- and anti-TNF-naive |
All csDMARD- and anti-TNF-naive |
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|
Placebo |
Combined UST (45mg/90mg) |
Placebo |
Combined UST (45mg/90mg) |
Placebo |
Combined UST (45mg/90mg) |
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Randomized pts, n |
248 |
499 |
56 |
123 |
45 |
101 |
|
ACR20 |
59 (23.8%)
|
237 (47.5%) p<0.001 |
10 (17.9%) |
66 (53.7%) p<0.001 |
9 (20.0%) |
57 (56.4%) p<0.001 |
|
ACR50 |
21 (8.5%) |
132 (26.5%) p<0.001 |
7 (12.5%) |
43 (35.0%) p=0.002 |
7 (15.6%) |
38 (37.6%) p=0.007 |
|
ACR70 |
7 (2.8%) |
64 (12.8%) p<0.001 |
2 (3.6%) |
24 (19.5%) p=0.006 |
2 (4.4%) |
20 (19.8%) p=0.017 |
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DAS28-CRP response |
90 (36.3%) |
327 (65.5%) p <0.001 |
17 (30.4%) |
87 (70.7%) p<0.001 |
16 (35.6%) |
71 (70.3%) p<0.001 |
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DAS28-CRP remission |
19 (7.7%) |
99 (19.8%) p <0.001 |
6 (10.7%) |
34 (27.6%) p=0.012 |
6 (13.3%) |
29 (28.7%) p=0.043 |
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Enthesitis (modified MASES index) |
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|
|
|
|
|
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Pts with enthesitis at baseline, n |
176 |
351 |
39 |
89 |
29 |
75 |
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Percent of patients with resolution of enthesitis at week 24
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19.9 (33/166) |
36.2 (123/340) p<0.001 |
18.9 (7/37) |
34.8 (31/89) p=0.077 |
21.4 (6/28) |
38.7 (29/75) p=0.096 |
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Dactylitis (0-3) |
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|
|
|
|
|
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Pts with dactylitis at baseline, n |
113 |
233 |
23 |
56 |
16 |
46 |
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Percent of patients with resolution of dactylitis at week 24
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25.5 (27/106)
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42.9 (97/226) p=0.003 |
22.7 (5/22) |
42.9 (24/56) p=0.121 |
20.0 (3/15) |
47.8 (22/46) p=0.118 |
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Change from baseline in total vdH-S score |
1.1 ± 4.2
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0.3 ± 1.7 p<0.001 |
0.8 ± 2.6
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0.2 ± 1.4 p=0.197 |
1.0 ± 2.8
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0.2 ± 1.4 p=0.105 |
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Data presented as n (%) or mean ± SD unless otherwise noted. ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology criteria; DAS28-CRP, 28-joint count disease activity score; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score ;UST, ustekinumab |
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To cite this abstract in AMA style:
Kavanaugh A, Chakravarty SD, Morgan GJ, Apaolaza MI, Kafka S, Hsia EC, Song M, You Y, McInnes IB. Efficacy of Ustekinumab in Psoriatic Arthritis Patients By Prior Treatment Exposure and Disease Duration [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-ustekinumab-in-psoriatic-arthritis-patients-by-prior-treatment-exposure-and-disease-duration/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-ustekinumab-in-psoriatic-arthritis-patients-by-prior-treatment-exposure-and-disease-duration/