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.
- Psoriatic Arthritis
- DMARDs (biologic)
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Handling editor Tore K Kvien
Contributors All authors fulfilled each of the four ICMJE criteria for authorship, including approving the revised draft for resubmission to the journal.
Funding Janssen Research & Development, LLC (Spring House, Pennsylvania, USA) provided funding for the studies contributing data to the reported analyses.
Competing interests AK has received funding for clinical research sponsored by Abbott, Amgen, Janssen and UCB and consultancy fees from AbbVie, Amgen, Janssen, Novartis and Pfizer. LP has received research support from/served as a clinical trial principal investigator for AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer and VBL; served as a consultant/speaker for AbbVie, Amgen, Boehringer, Celgene, Janssen, Leo-Pharma, Lilly, MSD, Merck-Serono, Novartis, Pfizer and Sandoz; and has been a Speakers Bureau/Advisory Board member for Celgene, Janssen, Novartis and Pfizer. ABG has consulting/advisory board agreements in place with Abbott Labs (AbbVie), Actelion, Akros, Amgen, Astellas, Baxalta, Beiersdorf, Bristol Myers Squibb Co, Canfite, Catabasis, Celgene, Coronado, CSL Behring Biotherapies for Life, Dermipsor, Genentech, Glaxo Smith Kline, Incyte, Janssen, Karyopharm, Lilly, Meiji Seika Pharma Co, Mitsubishi Tanabe Pharma Development America, Novartis, Novo Nordisk, Pfizer, Takeda, TEVA, UCB, Vertex and Xenoport; and has received research/educational grants (paid to Tufts Medical Center) from Amgen, Abbott (AbbVie), Baxalta, Celgene, Coronado, Dermira, Janssen, Levia, Lilly, Merck, Novartis, Pfizer and Xenoport. CR has received grant/research support from Janssen. YY, SL, MS and BR are employees of Janssen Research and Development, LLC. PR has received grant/research support from Janssen and has served as a speaker/consultant for AbbVie, BMS, Janssen, Novartis, Pfizer and UCB. IBM has received grant/research support from Astra Zeneca, BMS, Janssen, Pfizer and UCB and has served as a speaker/consultant for AbbVie, Astra Zeneca, BMS, Janssen, Novartis, Pfizer and UCB.
Ethics approval Multicentre trials.
Provenance and peer review Not commissioned; externally peer reviewed.