Session Information
Session Type: Late-Breaking Abstracts
Background/Purpose: PSUMMIT I ,through wk24, demonstrated efficacy and safety of ustekinumab (UST) in reducing signs and symptoms of active psoriatic arthritis (PsA) in a large, multicenter, double-blind, placebo (PBO)-controlled, Phase 3 trial. We report safety and efficacy results through wk52.
Methods: Adult PsA pts (n=615) with active disease (≥5 SJC and ≥5 TJC; CRP≥0.3mg/dL [ULN 1.0 mg/dL]) despite DMARD and/or NSAID therapy were randomized to UST45mg, 90mg, or PBO at wks 0, 4, and q12wks, thereafter. At wk16, pts with <5% improvement in TJC & SJC entered blinded early escape [EE] (PBO→UST45mg; UST45mg→90mg; 90mg→90mg). Stable concomitant MTX use was permitted but not mandated. Pts treated with prior anti-TNF agents were excluded. PBO pts who did not EE began UST 45mg at wk 24, 28 and q12w subsequently. Unlike wk24, available data at wk52 were used for EE pts rather than counting them as non-responders. Adverse events(AE) are reported through wk52.
Results: Improvement in clinical, joint, soft tissue, skin, and disability index increased notably from wk24 through wk52(Table). For example, the proportion of pts with ACR50 responses at wk24 compared to wk52 were 8.7%/38.0%, 24.9%/31.4%, 27.9%/37.0% for the PBO→UST, UST45mg, UST90mg groups, respectively. ACR responses were still numerically larger among pts not taking MTX at baseline compared to pts taking MTX at baseline. Among pts affected with enthesitis (n=425) or dactylitis (n=286) at baseline, improvements continued beyond wk24, with results at wk52 demonstrating median percent changes of -87.5, -83.3, -74.2 (enthesitis), and -100.00, -100.00, -100.00 (dactylitis) for the PBO→UST, UST45mg, and UST90mg groups, respectively). Average duration of follow-up through wk52 was 29.75, 50.41, and 50.21wks for the PBO→UST45mg, UST45mg, and UST90mg groups, respectively The proportions of pts with ≥1 AE were 41.3%, 66.8%, and 64.7%, respectively; pts with ≥1 serious AE were 5.3%, 5.9%, and 3.4%; pts with ≥1 serious infection were 0.5%, 1.0%, and 1.0%. No malignancies, TB, opportunistic infections, or deaths occurred through wk52. There were 3 major cardiovascular AEs reported after the PBO-controlled period in UST-treated pts.
Conclusion: In pts with active PsA, pts randomized to UST showed markedly reduced signs and symptoms of arthritis, improved physical function, enthesitis, and dactylitis, and alleviation of plaque psoriasis through wk52, at a rate similar to that reported for other biologic treatments through wk52. Safety was consistent with that observed during the PBO-controlled period with limited between-group differences observed.
Table: PSUMMIT efficacy results at Wk24 and Wk52
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|
PBO→UST (n=206) |
UST 45mg (n=205) |
UST 90mg (n=204) |
|
Wk 24† |
|||
|
ACR 20,% ACR 50, % ACR 70% DAS 28-CRP response, % Median HAQ-DI change from baseline Pts with ≥0.3 reduction in HAQ, % PASI75*, % Median improvement in TJ from baseline, % Median improvement in SJ from baseline,% Median % change in enthesitis score (modified MASES Index)** Median % change in dactylits score***
|
22.8 8.7 2.4 34.5 -0.0 28.2 11.0 13.61 21.54 0.0 0.0 |
42.4 24.9 12.2 65.9 -0.3 47.8 57.2 45.45 58.82 -42.9 -75.0 |
49.5 27.9 14.2 67.6 -0.3 47.5 62.4 51.51 60.00 -50.0 -70.8 |
|
Wk 52† |
|
|
|
|
ACR20, % ACR50, % ACR70, % DAS28-CRP response, % Median HAQ-DI change from baseline Pts with ≥0.3 improvement from baseline HAQ, % PASI75*, % Median improvement in TJ from baseline, % Median improvement in SJ from baseline,% Median % change in enthesitis score(modified MASES Index)** Median% change in dactylitis score***
|
65.2 38.0 16.3 74.5 -0.38 53.8 67.7 63.64 75.76 -87.5 -100.00 |
55.7 31.4 18.0 72.7 -0.25 47.4 70.1 60.00 73.68 -83.3 -100.00 |
60.3 37.0 21.2 74.6 -0.38 51.3 68.1 65.79 80.00 -74.2 -100.00 |
†In wk24 analysis, EE were considered ACR non-responders; in wk52 analysis EE who respond were counted as responders; p<0.001 for all parameters vs PBO at wk24 *Among pts affected at baseline, n=440 **Among pts affected at baseline, n=425 ***Among pts affected at baseline, n=286
Disclosure:
A. Kavanaugh,
Amgen, Abbott, BMS, Celgene, Roche, UCB, Janssen, Pfizer,
2;
I. B. McInnes,
Janssen Research Development,
2;
A. B. Gottlieb,
Janssen Research and Development, LLC,
;
L. Puig,
Janssen Research Development, LLC,
2;
P. Rahman,
Janssen Research and Development, LLC,
;
C. T. Ritchlin,
Janssen Research and Development, LLC,
;
S. Li,
Janssen Research Development, LLC,
3;
Y. Wang,
Janssen Research and Development, LLC,
3;
M. K. Doyle,
Janssen Research and Development, LLC,
3;
A. M. Mendelsohn,
Janssen Research & Development, LLC,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/continued-improvement-of-signs-and-symptoms-in-patients-with-active-psoriatic-arthritis-week-52-results-of-a-phase-3-multicenter-double-blind-placebo-controlled-study/