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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 Psoriatic Arthritis Patients with Spondylarthritis and Peripheral Arthritis

Last Updated: 01/02/2025

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 psoriatic arthritis (PsA) patients with spondylarthritis at baseline (27.6% of PSUMMIT I and PSUMMIT II population, including 32 bio-experienced).¹^,²

CLINICAL DATA

Subanalysis

Kavanaugh et al (2015)¹^,² evaluated the efficacy and safety of STELARA in adult PsA patients with 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.
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.

Efficacy

For a summary of efficacy results, refer to Table: PSUMMIT I and II - Efficacy Outcomes in Patients with Spondylitis and Peripheral Joint Involvement at Baseline.

PSUMMIT I and 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=156)
BASDAI 20/50/70 (%)^a	32.9/11.4/0	54.8/29.3/15.3	–	–
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 16.0 (99.93)^c	n=132 46.7 (48.69)^c P=0.017	n=60 53.06 (87.50)^d	n=127 54.76 (73.33)^d
Mean % change from baseline in dactylitis score^e	n=41 11.0 (77.67)^c	n=83 57.5 (62.84)^c P<0.001	n=39 69.76 (100.00)^d	n=82 68.94 (100.00)^d
ACR 20/50/70 (%)	n=92 22.8/3.3/1.1	n=164 43.9^f/25.6/11.0 ^fP<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 8.08 (6.706)	–	–
PASI 75 response^g	n=69 11.6%	n=137 63.5%; P<0.001	n=61 65.5%	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. ^bEnthesitis and dactylitis. ^cMean (standard deviation [SD]). ^dMean (median). ^eWith spondylitis and peripheral joint involvement at baseline. ^fACR20 only. ^gPatients 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).

Safety

Rates of adverse events (AE), serious adverse events (SAE), discontinuations due to AEs, and infections through the placebo-controlled period were 41.3%, 2.2%, 3.3% and 16.3% in the placebo group vs 34.8%, 1.2%, 0.6%, and 13.4% in the combined STELARA group, respectively.
Safety was reported to be consistent with that observed in the overall PsA population through 1 year.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 June 2024. 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 A, et al. 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. Arthritis Rheumatol. 2015;67(suppl 10).
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.