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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

STELARA® (ustekinumab)

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Use of STELARA in Adult Patients with Psoriatic Arthritis and Spondylarthritis and Peripheral Joint Involvement

Last Updated: 06/11/2025

Summary

  • The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
  • A post-hoc analysis from 2 phase 3 multicenter, double-blind, placebo-controlled studies, evaluated the efficacy and safety of STELARA in 256 adult patients with psoriatic arthritis (PsA) and spondylarthritis and peripheral joint involvement at baseline (27.6% of the PSUMMIT I and PSUMMIT II population).1,2

CLINICAL DATA

Phase 3 Subanalysis

Kavanaugh et al (2015)1,2 evaluated the efficacy and safety of STELARA in adult patients with PsA and spondylarthritis as well as peripheral arthritis from the PSUMMIT I and PSUMMIT II phase 3 clinical trials.

Study Design/Methods

  • Adult patients with active PsA were randomized to receive placebo, STELARA 45 mg, or STELARA 90 mg at weeks 0, 4, and every 12 weeks thereafter.
  • Patients with <5% improvement in swollen joint count (SJC) and tender joint count (TJC) entered early escape in a blinded fashion at week 16.
  • At weeks 24, patients receiving placebo crossed over to STELARA 45 mg and continued STELARA treatment at week 28 and every 12 weeks thereafter.
  • At baseline, week 12, and week 24, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were collected.

Results

Patient Characteristics
  • Of the 256 patients with spondylarthritis at baseline, 92 received placebo and 164 received STELARA.2
  • At baseline, patients were receiving methotrexate (MTX; 47.7%), nonsteroidal antiinflammatory drugs (NSAIDs; 77%), and low-dose oral corticosteroids (20.7%), which was consistent with the overall population.1,2
Efficacy

PSUMMIT I and PSUMMIT II - Efficacy Outcomes in Patients with Spondylitis and Peripheral Joint Involvement at Baseline1,2
Week 24
Week 52
Placebo
(n=92)
STELARA
Combined
(n=164)
Placebo →
STELARA
45 mg
(n=81)
STELARA
Combined
(n=164)
BASDAI responses at week 24, n (%)a
   BASDAI20
26 (32.9)
86 (54.8)
-
-
P-value
0.002
   BASDAI50
9 (11.4)
46 (29.3)
-
-
P-value
0.002
   BASDAI70
0
24 (15.3)
-
-
P-value
<0.001
Mean improvement in BASDAI score (SD)
0.74 (1.606)
2.05 (2.249)
-
-
Mean % improvement from baseline in entheses score (MASES index)b
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 from baseline in dactylitis scoreb
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)
ACR 20/50/70 (%)
n=92
22.8/3.3/1.1
n=164
43.9c/25.6/11.0
cP<0.001
n=81
65.4/39.5/16.0
n=156
62.8/34.6/19.2
Mean (SD) improvement from baseline in HAQ-DI
n=92
0.11 (0.386)
n=164
0.33 (0.533)
P<0.001
n=81
0.39 (0.42)
n=156
0.37 (0.55)
Mean (SD) improvement from baseline in DLQI
n=64
1.97 (5.252)
n=134
8.09 (6.706)
-
-
PASI 75 responsed
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 baseline (peripheral joints)
1.51 (6.41)
0.00 (1.69);
P=0.003
3.04 (11.86)
0.25 (2.13)
Abbreviations: ACR, American College of Rheumatology; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire- Disability Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; PASI, psoriatic area and severity index; SD, standard deviation; vdH-S, van der Heijde-Sharp score.
Patients who did not receive STELARA excluded.
aBASDAI not collected at week 52.
bMean (median).
cACR20 only.
dPatients with ≥3% body surface area psoriasis involvement with spondylitis and peripheral joint involvement at baseline.
  • The mean (standard deviation [SD]) improvement in the score for the BASDAI question related to the overall level of axial disease (neck, back, or hip pain) was greater in the combined STELARA group (1.85 [2.678]) than in the placebo group (0.24 [2.309]; P<0.001).2
Safety
  • Rates of adverse events (AEs), serious adverse events (SAEs), discontinuation due to AEs, and discontinuation due to infections through the placebo-controlled period were 34.8% vs 41.3%, 1.2% vs 2.2%, 0.6% vs 3.3%, and 13.4% vs 16.3% for STELARA vs placebo, respectively.2

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 15 May 2025.

Summarized in this response are relevant data from the PSUMMIT I and PSUMMIT II clinical studies.

 

References

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1 Kavanaugh A, Puig L, Gottlieb AB, et al. Efficacy and safety of ustekinumab in psoriatic arthritis patients with spondylitis and peripheral joint involvement: results from 2 phase 3, multicenter, double-blind, placebo-controlled study. Poster presented at: American College of Rheumatology; November 6-11, 2015; San Francisco, CA.  
2 Kavanaugh A, Puig L, Gottlieb AB, et al. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016;75(11):1984-1988.  
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