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).
OBJECTIVE
To evaluate ustekinumab efficacy and safety in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (termed the 'spondylitis subset').


METHODS
Adults with active PsA (PSUMMIT-1/PSUMMIT-2, n=615/312) were randomised to ustekinumab 45 mg, 90 mg or placebo at week 0/week 4/q12 week. At week 16, patients with <5% improvement in tender and swollen joints entered blinded early escape. A subset of patients with physician-identified spondylitis was evaluated with spondylitis-specific assessments, including Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score employing C reactive protein (ASDAS-CRP), through week 24.


RESULTS
256/927 (27.6%) PSUMMIT-1/PSUMMIT-2 patients (placebo/ustekinumab, n=92/164) comprised the evaluable spondylitis subset. At week 24, in this analysis subset, significantly more patients achieved BASDAI20/50/70 responses (54.8%/29.3%/15.3% vs 32.9%/11.4%/0%; p≤0.002), improvement in BASDAI question 2 concerning axial pain (1.85 vs 0.24; p<0.001) and mean per cent ASDAS-CRP improvements (27.8% vs 3.9%; p<0.001) for ustekinumab versus placebo recipients, respectively. Comparable to the overall study population, significant improvements were also achieved in psoriasis, peripheral arthritis, enthesitis, dactylitis, physical function and peripheral joint radiographs in the spondylitis subset.


CONCLUSIONS
In this post-hoc analysis of PsA patients with baseline peripheral arthritis and physician-reported spondylitis, ustekinumab-treated patients demonstrated significant improvements in axial signs and symptoms through week 24.


BACKGROUND
PSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.
Division of Rheumatology, Allergy, and Immunology, University of California-San Diego, La Jolla, California, USA.
Arthur
A
Kavanaugh
Department of Dermatology, Hospital de la Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain.
Lluis
L
Puig
Department of Dermatology, Tufts Medical Center, Boston, Massachusetts, USA.
Alice B
AB
Gottlieb
Department of Dermatology, University of Rochester, Rochester, New York, USA.
Christopher
C
Ritchlin
Department of Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Yin
Y
You
Department of Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Shu
S
Li
Department of Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Michael
M
Song
Department of Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Bruce
B
Randazzo
Department of Dermatology, Memorial University, St. Johns, Newfoundland, Canada.
Proton
P
Rahman
College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Iain B
IB
McInnes
D000328:Adult; D015535:Arthritis, Psoriatic / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007596:Joints / Q000000981:diagnostic imaging; D008297:Male; D010489:Periarthritis / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011859:Radiography; D013166:Spondylitis / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016896:Treatment Outcome; D000069549:Ustekinumab / Q000008:administration & dosage*
D003879:Dermatologic Agents; D000069549:Ustekinumab
DMARDs (biologic); Psoriatic Arthritis; Spondyloarthritis