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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)
  1. Arthur Kavanaugh1,
  2. Lluis Puig2,
  3. Alice B Gottlieb3,
  4. Christopher Ritchlin4,
  5. Yin You5,
  6. Shu Li5,
  7. Michael Song6,
  8. Bruce Randazzo6,7,
  9. Proton Rahman8,
  10. Iain B McInnes9
  1. 1Division of Rheumatology, Allergy, and Immunology, University of California-San Diego, La Jolla, California, USA
  2. 2Department of Dermatology, Hospital de la Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain
  3. 3Department of Dermatology, Tufts Medical Center, Boston, Massachusetts, USA
  4. 4Department of Dermatology, University of Rochester, Rochester, New York, USA
  5. 5Department of Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  6. 6Department of Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  7. 7University of Pennsylvania, Philadelphia, Pennsylvania, USA
  8. 8Department of Dermatology, Memorial University, St. Johns, Newfoundland, Canada
  9. 9College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
  1. Correspondence to Professor Arthur Kavanaugh, Department of Rheumatology, University of California-San Diego, 9500 Gilman Drive, MC 0943, La Jolla, CA 92093-0943, USA; akavanaugh{at}ucsd.edu

Abstract

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.

Trial registration number PSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.

  • Psoriatic Arthritis
  • DMARDs (biologic)
  • Spondyloarthritis

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Footnotes

  • 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.

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