Session Information
Date: Tuesday, November 10, 2015
Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: To evaluate ustekinumab(UST) in a
subgroup of psoriatic arthritis (PsA) pts with physician diagnosed spondylarthritis,
as well as peripheral arthritis, from the PSUMMIT 1 & 2 trials.
Methods: Adult PsA pts with active disease were
randomized to UST45mg, 90mg, or PBO at wks 0,4, and q12wks, thereafter. PBO-pts
crossed over to UST45mg at wks24 and 28 followed by q12wk dosing. At wk16, pts
with <5% improvement in TJC & SJC entered blinded early escape [EE]. This
post hoc analysis evaluated efficacy and safety in the subgroup of PsA patients
with physician diagnosed spondylarthritis at baseline from the PSUMMIT trials (PSUMMIT
1 [bio-naïve] and PSUMMIT 2 [bio-naïve and bio-experienced]). BASDAI scores were
collected at baseline and wks12 and 24; BASDAI question (#2) related to overall
level of axial disease neck, back or hip pain was also assessed separately.
Results: 256 (28% of PSUMMIT 1 &2 population, including
32 bio-experienced) randomized pts (92 PBO, 164 UST combined) had spondylarthritis
at baseline. In this sub-group 80.5% had enthesitis and 51.6% had dactylitis at
baseline; in the overall population, 71.4% and 45.6% had enthesitis and
dactylitis, respectively. Consistent with the overall population, at baseline,
about 50% of patients used MTX, 77% NSAIDs, and 20.7% low dose oral
corticosteroids. More UST-treated pts achieved
BASDAI20/50/70 responses vs PBO at wk24(Table). The observed changes in the median
score of the BASDAI question related to the overall level of axial disease
neck, back or hip pain were also similar to the total BASDAI score changes for
both groups, -0.45 vs -1.65, between PBO and combined UST groups,
respectively. Other clinical efficacy and
radiographic progression data in this subgroup are summarized (Table). During
the PBO-controlled period, AE rates for PBO vs combined UST-treated groups were
41.3% vs 34.8%; SAEs were 2.2% vs 1.2% discontinuations due to AEs were 3.3% vs
0.6%; and infections were 16.3% vs 13.4%). Through 1yr, safety was consistent
with the overall PsA population.
Conclusion: In this post-hoc analysis, UST significantly
improved axial symptoms in a subgroup of PsA patients who also had physician
diagnosed spondylarthritis. Reponses in other PsA domains and safety were similar
to that observed in the overall PsA study population.
|
Table: PSUMMIT 1 and 2-Efficacy Outcomes in Patients with Spondylitis and Peripheral Joint Involvement at Baseline (BL) |
||||
|
|
Wk 24 |
Wk 52 |
||
|
|
PBO |
UST Combined |
PBO→ 45mg |
UST Combined |
|
|
92 |
164 |
81 |
156 |
|
BASDAI20/50/70† |
N=92 32.9%/11.4%/0% |
N=164 54.8%/29.3%/15.3% |
– |
– |
|
Change in BASDAI score (median) |
N=92 -0.51 |
N=164 -1.60 |
– |
– |
|
Mean % change (median) from BL entheses score (MASES index)* |
N=63 -16.01(-26.67) |
N=132 -46.66(-50.00) P=0.017 |
N=60 -53.06(-87.50) |
N=127 -54.76(-73.33) |
|
Mean % change(median) from BL dactylitis score** |
N=41 -11.03(0.00) |
N=83 -57.48(-88.89) P<0.001 |
N=39 -69.76(-100.00) |
N=82 -68.94(-100.00) |
|
ACR20 /ACR50/ ACR70 (%) |
N=92 22.8/3.3/1.1 |
N=164 43.9^/25.6/11.0 ^P=0.001 |
N=81 65.4/39.5/16.0 |
N=156 62.8/34.6/19.2 |
|
Mean (SD) change from BL HAQ-DI |
N=92 -0.11(0.39) |
N=164 -0.33(0.53) P<0.001 |
N=81 -0.39(0.42) |
N=156 -0.37(0.55) |
|
PASI 75 response*** |
N=69 11.6% |
N=137 63.5% P<0.001 |
N=61 65.6% |
N=129 70.5% |
|
Total vdH-S mean change from BL (peripheral joints) |
1.51(6.41) |
0.00(1.69) P=0.003 |
3.04(11.86) |
0.25(2.13) |
Pts who did
not receive UST excluded. †BASDAI not collected at wk 52 ^ACR20 only, *enthesitis and dactylitis **with spondylitis
and peripheral joint involvement at BL; *** pts with ≥3% BSA
psoriasis involvement with spondylitis and peripheral joint involvement at BL
To cite this abstract in AMA style:
Kavanaugh A, Puig L, Gottlieb AB, Ritchlin CT, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and Safety of Ustekinumab in Psoriatic Arthritis Patients with Spondylarthritis As Well As Peripheral Arthritis: Results from 2 Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-ustekinumab-in-psoriatic-arthritis-patients-with-spondylarthritis-as-well-as-peripheral-arthritis-results-from-2-phase-3-multicenter-double-blind-placebo-controlled-st/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-ustekinumab-in-psoriatic-arthritis-patients-with-spondylarthritis-as-well-as-peripheral-arthritis-results-from-2-phase-3-multicenter-double-blind-placebo-controlled-st/