Session Information
Date: Tuesday, October 23, 2018
Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: In PSUMMIT 1&2, Phase 3 trials of ustekinumab (UST) in adults w/ active psoriatic arthritis (PsA), 30.1% & 22.4% of patients (pts) had peripheral arthritis w/ physician-reported spondylitis (PA‑PRS), respectively. To evaluate the proportion of anti-tumor necrosis factor (TNF)-naïve pts w/ PA-PRS from pooled data in PSUMMIT 1&2 treated w/ UST achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) responses and other axial disease response measures.
Methods: Pts had active PsA (≥5 swollen& tender joints, CRP ≥3.0mg/L) for ≥6 mo despite treatment w/ csDMARDs &/or NSAIDs (PSUMMIT 1&2) &/or anti-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 & every 12 wks. PBO pts crossed over to UST 45mg at wk24. At wk16, early escape (PBOàUST45mg; UST45mgàUST90mg; UST90mgàUST90mg) was possible. The proportion of pts achieving ASDAS responses of inactive disease (<1.3), major improvement (decrease ≥2.0), & clinically important improvement (decrease ≥1.1) at wks 12 & 24 were calculated. Modified Bath Ankylosing Spondylitis Disease Activity Index (mBASDAI) scores were calculated at wks 12 & 24 (based upon BASDAI w/o Q#3).
Results: Of 747 TNF-naïve pooled pts, 223 had PsA w/ PA-PRS. For the PA-PRS subset, baseline mean scores included BASDAI 6.57 (UST 45mg), 6.60 (UST 90mg), and 6.37 (PBO); ASDAS 3.86 (UST 45mg), 3.90 (UST 90mg), 3.68 (PBO); BASDAI Q#2 6.62 (UST 45mg), 6.84 (UST 90mg), 6.14 (PBO); and mBASDAI 6.52 (UST 45mg), 6.56 (UST 90mg), 6.27 (PBO). A numerically greater change from baseline in mBASDAI was achieved in both UST 45mg & 90mg groups vs PBO at both wks 12 and 24 (Table 1). Additionally, significantly greater proportions of pts in both UST 45mg & 90mg groups vs PBO achieved ASDAS inactive disease by wk24 (Table 2). Similarly, by wk24, significantly greater proportions of pts in both 45mg & 90mg UST groups vs PBO achieved ASDAS major improvement and clinically important improvement.
Conclusion: Approximately half of UST-treated PA-PRS pts attained meaningful improvements in ASDAS by wk24, and similar numerically greater changes from baseline were observed in mBASDAI. These results are limited and should be interpreted with caution as this was a heterogenous patient group in the absence of definitive imaging, and improvements in extra-axial domains, such as peripheral arthritis and enthesitis, may have contributed to the changes in ASDAS and mBASDAI scores. Further research is needed to examine the efficacy of UST in treatment of spondylitis in PsA patients.
|
Table 1. Mean change from baseline in mBASDAIa in PA-PRS subset at wk 12 & 24 in PSUMMIT 1&2 |
||||
|
|
PBO |
UST 45mg |
UST 90mg |
UST Combined |
|
PA-PRS Subset, n |
84 |
66 |
73 |
139 |
|
Wk 12, n Mean change (SD) |
77 -0.52 (1.47) |
61 -1.81 (1.84) |
70 -1.78 (2.11) |
131 -1.79 (1.98) |
|
Wk 24, n Mean change (SD) |
71 -0.59 (1.58) |
63 -1.73 (2.13) |
69 -2.41 (2.20) |
132 -2.09 (2.18) |
|
BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; mBASDAI=modified BASDAI; PA-PRS=peripheral arthritis with physician-reported spondylitis; PBO=placebo; SD=standard deviation; UST=ustekinumab amBASDAI scores were calculated based on the BASDAI with question #3 removed (0.25[F+S+E+0.5×DURATION]). |
||||
|
Table 2. PA-PRS subset achieving ASDAS responses at wk 12&24 in PSUMMIT 1&2 |
||||
|
|
PBO |
UST 45mg |
UST 90mg |
UST Combined |
|
PA-PRS Subset, n |
84 |
66 |
73 |
139 |
|
Wk 12, ASDAS, n |
78 |
61 |
70 |
131 |
|
ASDAS <1.3, inactive disease, n (%) |
2 (2.6) |
4 (6.6) |
5 (7.1) |
9 (6.9) |
|
ASDAS improvement, n |
77 |
60 |
70 |
130 |
|
Major improvement, decrease ≥2.0, n (%) |
2 (2.6) |
8 (13.3) |
10 (14.3) |
18 (13.8) |
|
Clinically important improvement, decrease ≥1.1, n (%) |
9 (11.7) |
25 (41.7) |
29 (41.4) |
54 (41.5) |
|
Wk 24, ASDAS, n |
72 |
64 |
69 |
133 |
|
ASDAS <1.3, inactive disease, n (%) |
0 (0) |
4 (6.3)*** |
8 (11.6)** |
12 (9.0)** |
|
ASDAS improvement, n |
71 |
62 |
69 |
131 |
|
Major improvement, decrease ≥2.0, n (%) |
1 (1.4) |
9 (14.5)** |
19 (27.5)* |
28 (21.4)* |
|
Clinically important improvement, decrease ≥1.1, n (%) |
9 (12.7) |
27 (43.5)* |
38 (55.1)* |
65 (49.6)* |
|
ASDAS=Ankylosing Spondylitis Disease Activity Score; PA-PRS=peripheral arthritis with physician-reported spondylitis; PBO=placebo; UST=ustekinumab *p<0.001; **p<0.01; ***p<0.05 |
||||
To cite this abstract in AMA style:
Helliwell P, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Kavanaugh A, Gensler LS. Efficacy of Ustekinumab on Spondylitis-Associated Endpoints in TNF-Naïve Active Psoriatic Arthritis Patients with Physician-Reported Spondylitis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/efficacy-of-ustekinumab-on-spondylitis-associated-endpoints-in-tnf-naive-active-psoriatic-arthritis-patients-with-physician-reported-spondylitis/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-ustekinumab-on-spondylitis-associated-endpoints-in-tnf-naive-active-psoriatic-arthritis-patients-with-physician-reported-spondylitis/