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FRI0456 Association between Improvement in Enthesopathy and Quality of Life: Results from Anti-Tnf-Naïve Patients with Psoriatic Arthritis in Two Phase 3 Ustekinumab Trials
  1. I.B. McInnes1,
  2. L. Puig2,
  3. A.B. Gottlieb3,
  4. C. Ritchlin4,
  5. Y. You5,
  6. M. Song5,
  7. S. Kafka6,
  8. K.L. Tang5,
  9. G.J. Morgan6,
  10. P. Rahman7,
  11. A. Kavanaugh8,
  12. on behalf of the PSUMMIT I and II Study Groups
  1. 1University of Glasgow, Glasgow, United Kingdom
  2. 2Universitat Autònoma de Barcelona, Barcelona, Spain
  3. 3Tufts Medical Center, Boston
  4. 4University of Rochester, Rochester
  5. 5Janssen Research & Development, LLC, Spring House
  6. 6Janssen Scientific Affairs, LLC, Horsham, United States
  7. 7Memorial Hospital, St. John's, Canada
  8. 8University of California-San Diego, La Jolla, United States

Abstract

Objectives To assess the relationship between changes in enthesopathy and in function/health-related quality of life (HRQoL) in anti-TNF-naïve patients (pts) with psoriatic arthritis (PsA) receiving treatment with ustekinumab (UST).

Methods Adult pts in 2 Phase 3 trials (n=747 anti-TNF naive) with active PsA (≥5 SJC and ≥5 TJC;CRP≥0.3mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg, 90mg, or PBO at weeks 0, 4, and q12weeks. Stable concomitant MTX was permitted but not mandated. At week16, pts with <5% improvement in TJC & SJC entered blinded early escape (PBO→UST45mg; UST45mg→90mg; 90mg→90mg). Presence or absence of enthesopathy, HAQ-DI, and SF-36 were assessed at baseline and week 24. In this post-hoc analysis, enthesopathy of the Achilles tendon and plantar fascia was assessed as present or absent. Pts were categorized thereafter as follows: improved (enthesopathy present at baseline, but not at week 24), worsened (enthesopathy present at week 24, but not at baseline), and unchanged. Pts with an enthesopathy assessment missing at either time point were included in the unchanged category; those with enthesopathy data missing at both time points were excluded. Early escape pts were also excluded from this analysis. Improvements in HRQoL (assessed by the SF-36 PCS and MCS and physical function (HAQ-DI) were assessed by enthesopathy response category.

Results A total of 591 anti-TNF-naïve pts from both trials were included in the analysis; 45% of pts were female, mean age was 47 years, mean PsA duration was 6.7 years, and 74% had ≥3% body surface area affected at baseline. The proportion of pts with enthesopathy at baseline was similar in the combined UST (46.5%) and placebo (49.4%) groups. At week 24, the proportions of pts with enthesopathy were 22.8% and 35.9% for the combined UST and placebo groups, respectively. Across all pts, those who had an improvement in enthesopathy had a greater improvement in functioning and HRQoL, compared with those who did not (p<0.05; Table). When the analysis was restricted to those who achieved an ACR 20 response, pts with an improvement in enthesopathy showed a trend of greater improvement in functioning and HRQoL compared to those who had worsened (Table).

Table 1

Conclusions There is an association between improvement in enthesopathy of the Achilles tendon and plantar fascia and improvement in physical function and quality of life in anti-TNF-naïve pts with PsA in 2 UST trials. Some, but not all, of this improvement may be explained by improvements in peripheral arthritis.

Disclosure of Interest I. McInnes Grant/research support from: AbbVie, BMS, Janssen, MSD, Novartis, Pfizer, L. Puig Grant/research support from: AbbVie, Amgen, Boehringer, Celgene, Eli Lilly, Janssen, Leo-Pharma, Merck/Schering-Plough, Merck-Serono, Novartis, Pfizer, Sandoz, and VBL, A. Gottlieb Grant/research support from: Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Levia, Merck, Novartis, Pfizer, and Xenoport, Consultant for: AbbVie, Actelion, Akros, Amgen, Astellas, Beiersdorf, Bristol-Myers Squibb, Canfite, Catabasis, Celgene, CSL Behring Biotherapies for Life, Coronado, Dermipsor, Eli Lilly, GlaxoSmithKline, Incyte, Janssen, Karyopharm, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Development America Inc., Novartis, Novo Nordisk, Pfizer, Takeda, TEVA, UCB, Vertex, and Xenoport, C. Ritchlin Grant/research support from: Amgen, Janssen, and UCB, Consultant for: AbbVie, Amgen, Janssen, Regeneron, Roche, and UCB, Y. You Employee of: Janssen Research & Development, LLC, M. Song Employee of: Janssen Research & Development, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, K. Tang Employee of: Janssen Research & Development, LLC, G. J. Morgan Employee of: Janssen Scientific Affairs, LLC, P. Rahman Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, and Novartis, A. Kavanaugh Grant/research support from: AbbVie, Amgen, Janssen, and UCB, Consultant for: AbbVie, Amgen, Janssen, Novartis, and Pfizer

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