Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To evaluate the association of improvements in tender and swollen joint counts (TJC, SJC), psoriasis skin involvement, and dactylitis/enthesitis (in patients affected at baseline) with improvement in physical function using data from the ustekinumab (UST) PSUMMIT 1 trial in psoriatic arthritis (PsA) pts.
Methods: Adult PsA pts (n=615) with active disease (≥5 SJC and ≥5 TJC;CRP≥0.3mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg, 90mg, or PBO at wks 0, 4, and q12wks. Pts treated with prior anti-TNF agents were excluded. Stable concomitant MTX was permitted but not mandated. At wk16, pts with <5% improvement in TJC and SJC entered blinded early escape (PBO→UST45mg; UST45mg→90mg; 90mg→90mg). PBO-treated patients subsequently crossed over to UST45mg at wk24. Pts received q12wks dosing to wk88, with final efficacy evaluation at wk100 and safety assessment at wk108. The percent change from baseline in enthesitis score, dactylitis score, TJC and SJC by HAQ responder status (response defined as achieving≥0.3 point improvement from baseline) was assessed at wks 52 and 100.The correlation between change from baseline in HAQ and percent change from baseline in TJC, SJC, enthesitis and dactylitis were also determined at wks 52 and 100.
Results: At baseline; mean(median) TJC and SJC values were 23.5(20.0) and 13.5(10.0), respectively. 441(71.7%) and 296(48.1%) patients had enthesitis or dactylits at baseline, respectively; 440(71.7%) patients had >3% BSA psoriasis skin involvement. Improvements in TJC, SJC, dactylitis and enthesitis, and PASI scores were generally greater in HAQ responders compared with HAQ non-responders at both wk52 and wk100(Table). Significant correlations were demonstrated between the HAQ change from baseline with percent change in outcomes parameters for all outcomes(Table) at wk52 and wk100. In addition, associations were observed at earlier time points at wk24/wk28 [TJC -0.39/-0.36; SJC -0.27/-0.20; enthesitis 0.30/0.28(all p<0.0001); dactylitis 0.19/0.18 (p=0.001/p=0.002); PASI -0.24/-0.10(p<0.0001/p=0.0397)].
Conclusion: Based on this post-hoc analysis of the PSUMMIT 1 population, improvements in physical function as measured by HAQ were associated with improvements in TJC, SJC, dactylitis and enthesitis, and these correlations were observed as early as week 24 and continued through week100 . Improvement in skin disease was also associated with improvements in HAQ.
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Table: Summary of percent change from baseline at wk52 and wk100 in HAQ responders; randomized patients at baseline [mean(median)]
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PBO → 45 mga (n=189)
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UST 45mg (n=205)
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UST 90mg (n=204)
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Spearman Correl coeff
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p-value
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HAQ response at wk52/wk100
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Responders |
Non-responders |
Responders |
Non-responders |
Responders |
Non-responders |
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TJC Wk52
Wk100
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N=98 71.8(78.4) N=89 76.6(80.0) |
N=84 35.9(38.7) N=88 29.1(25.4)
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N=91 61.6(75) N=85 74.6(90.0) |
N=103 40.6(48.7) N=90 37.3(40.8) |
N=97 68.5(77.8) N=91 76.7(87.5) |
N=92 35.3(42.9) N=84 33.4(25.0) |
N=572 -0.329 N=534 -0.430 |
<0.001 <0.001 |
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SJC Wk52
Wk100
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N=98 73.4(85.7) N=89 80.1(83.3) |
N=84 42.1(53.7) N=88 44.0(54.8) |
N=91 69.0(87.5) N=85 79.1(92.3) |
N=103 52.5(66.7) N=90 44.0(48.5) |
N=97 70.4(84.6) N=91 84.2(93.3) |
N=92 46.2(61.8) N=84 46.4(58.6) |
N=572 -0.434 N=534 -0.500 |
<0.001 <0.001 |
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Entheses score (modified MASES index)* Wk52
Wk100
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N=68 -58.7(-100.0) N=58 -71.5(-100.0) |
N=54 -28.2(-40.0) N=60 -7.3(-17.4) |
N=69 -55.4(-100.0) N=60 -69.5(-100.0) |
N=65 -34.7(-66.7) N=59 -22.6(-50.0) |
N=71 -66.9(-100.0) N=65 -73.7(-100.0) |
N=71 -46.1(-66.7) N=65 -42.6(-50.0) |
N=405 0.286 N=374 0.370 |
<0.001 <0.001 |
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Dactylitis score** Wk52
Wk100
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N=53 -76.6(-100.0) N=48 -81.1(-100.0) |
N=31 -55.5(-78.6) N=36 -43.8(-88.9) |
N=46 -48.8(-100.0) N=42 -75.6(-100.0) |
N=51 -59.7(-100.0) N=48 -67.5(-100.0) |
N=49 -56.4(-100.0) N=50 -85.6(-100.0) |
N=42 -53.7(-75.0) N=36 -18.8(-83.4) |
N=277 0.182 N=265 0.286 |
0.002 <0.001 |
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PASI score*** Wk52
Wk100
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N=74 80.1(90.1) N=63 71.4(91.2) |
N=56 71.5(79.2) N=58 68.5(81.4) |
N=63 82.6(93.8) N=62 84.7(93.5) |
N=71 64.2(85.7) N=57 60.3(87.0) |
N=74 77.1(90.3) N=67 84.9(97.6) |
N=66 74.0(88.7) N=59 69.8(86.7) |
N=404 -0.17 N=366 -0.24 |
0.0006 <0.0001 |
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aPatients who did not receive UST are excluded; *Randomized patients with enthesitis at baseline PBO→45mg n=128, 45mg n=142, 90mg n=154; **Randomized patients with dactylitis at baseline PBO→45mg n=87 45mg n=101, 90mg n=99; ***Randomized patients with ≥3% BSA psoriasis skin involvement at baseline PBO→45mg n=136 45mg n=145, 90mg n=149
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Disclosure:
A. Kavanaugh,
AbbVie,
2,
Amgen,
2,
Roche Pharmaceuticals,
2,
Pfizer Inc,
2,
Janssen Pharmaceutica Product, L.P.,
2,
UCB,
2,
BMS,
2,
Astellas,
2;
L. Puig Sanz,
Abbott, Amgen, Celgene, Janssen Research & Development, LLC., Merck/Schering-Plough, and Pfizer,
2;
A. B. Gottlieb,
Amgen Inc., Astellas, Akros, Centocor (Janssen), Inc. Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbott Labs. (Abbvie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd., Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopha,
5,
Amgen Inc., Astellas, Akros, Centocor (Janssen), Inc. Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbott Labs. (Abbvie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd., Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopha,
9,
Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck,
2;
C. T. Ritchlin,
Amgen, Janssen, and UCB ,
2,
Abbott, Amgen, Janssen, Regeneron, Roche, and UCB,
5;
S. Li,
Janssen Research & Development, LLC.,
3,
Johnson & Johnson,
1;
Y. You,
Janssen Research & Development, LLC.,
3;
A. M. Mendelsohn,
Janssen Research & Development, LLC.,
3;
M. Song,
Janssen Research & Development, LLC.,
3;
P. Rahman,
Abbott, Amgen, Janssen, Merck/Schering-Plough, and Wyeth,
2;
I. B. McInnes,
Consulting fees from Novartis, Amgen, Janssen, BMS, Pfizer, UCB, Abbvie, Celgene and Lilly,
5.
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